The purpose of this study is to determine whether epidural levobupivacaine applied for the purpose of post-operative analgesia compared to systemic analgesia with morphine leads to better pain control, stronger suppression of the inflammatory response and the production of inflammatory mediators, faster recovery of patients and consequently less incidence of postoperative cognitive dysfunction (POCD) in elderly patients after surgical treatment of femoral fractures.
The research will be carried out at the Department of Surgery at Clinical Hospital Centre(CHC) Osijek after approval by the Ethics Committee of CHC Osijek and will be organized as a prospective randomized trial. Respecting the including and excluding criteria for participation in the study, the research will include 70 patients aged 65 years and over who are undergoing surgery for proximal femur fractures and will be operated with the same operating technique (osteosynthesis with nail). All participants will receive the same type of anesthesia and one of two forms of post-operative analgesia, so it will be divided into two groups (35 patients) depending on which form of post-operative analgesia receive. Randomization will be performed by drawing an envelope in which the specified one or other form of post-operative analgesia will be written. The study will be stopped in case of serious complications life-threatening (excessive sedation, respiratory insufficiency, hemodynamic instability and profound hypotension, heart rhythm disorders), which could possibly be related to the administration of drugs used for postoperative analgesia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
Clinical Hospital Centre Osijek
Osijek, Croatia
Interleukin-6 Concentration in Peripheral Blood.
Measurement will be done before and 24 and 72 hours after the surgery.
Time frame: Before, 24 and 72 hours after the surgery
Changes in Cognitive Function
Assessment of cognitive function will be done using the Mini-mental state examination (MMSE) rating scales before and 24,48,72,96 and 120 hours after the surgery at the same time every morning. Mini-Mental State Examination Scale: minimum score is 0 and maximum score is 30; the severity of cognitive impairment: no cognitive impairment=25-30; mild cognitive impairment=19-24; moderate cognitive impairment=10-18; and severe cognitive impairment\<9. Higher scores mean a better and lower scores mean a worse outcome.
Time frame: Before, 24,48,72,96 and 120 hours after the surgery
Changes in C-reactive Protein (CRP) Levels
Measurement will be done before and 24,72 and 120 hours after the surgery.
Time frame: Before, 24,72 and 120 hours after the surgery
Changes in Fibrinogen Concentrations in Peripheral Blood
Measurement will be done before and 24,72 and 120 hours after the surgery.
Time frame: Before, 24,72 and 120 hours after the surgery
Changes in Pain Intensity
Assessment will be done using Numeric Rating Scale (NRS). During the first 72 hours after the surgery assessment will be done every 3 hours, after that assessment will be done 3 times daily. Median of 8 time points measurements during the first 24, 48 and 72 hours after the surgery will be reported. After that, median of 3 time points will be reported from the 4. to 6. postoperative day and on the day of discharge. Minimum score 0 and maximum score 10 ( 0-No Pain; 1-3 Mild Pain; 4-6 Moderate Pain; 7-10 Severe Pain ). Higher scores mean a worse and lower scores mean a better outcome.
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Time frame: During the first 72 hours after the surgery assessment will be done every 3 hours, after that assessment will be done 3 times daily until discharge
Postoperative Hospital Stay
Duration of postoperative hospital stay in days
Time frame: 14 days